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Fecal Microbiota Transplantation

FMT for Autism

Phase 1

Waitlist Available

Led By Sonia Michail, MD

Research Sponsored by Children's Hospital Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: 5-17 who have been diagnosed with non-syndromic ASD-s

Needs upper GI endoscopy

Must not have

Subjects able to give consent/assent but unwilling to give informed consent/assent

Subjects with significant renal and liver dysfunction (creatinine > 2 mg/dl and direct bilirubin > 2 mg/dl)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Summary

This trial is testing if fecal transplants can help treat autism by improving gastrointestinal symptoms and repetitive behaviors.

Who is the study for?

This trial is for children aged 5-17 with Autism Spectrum Disorder (ASD) who have gastrointestinal symptoms. They must be diagnosed using specific autism and GI symptom assessments, need an upper GI endoscopy, and not have any severe sensory or motor problems, genetic syndromic disorders, significant renal/liver dysfunction, immunodeficiency conditions, or severe food allergies.

What is being tested?

The study tests if fecal microbiota transplantation (FMT)—transferring stool from a healthy donor to the intestines—helps kids with ASD. Participants are randomly chosen to receive either FMT or a saline placebo through an endoscopy into the jejunum.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects of FMT may include abdominal discomfort, bloating, diarrhea or constipation. There's also a risk of infection transmission from donor stool.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 5 and 17 years old and have been diagnosed with autism.

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I need an upper GI endoscopy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am capable of giving consent but choose not to.

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My kidney and liver functions are normal.

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I have a weakened immune system due to a condition like HIV, cancer, or after an organ transplant.

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I have a genetic disorder or severe sensory/motor issues like blindness or seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measures, safety and tolerability

Secondary study objectives

Measures, symptom improvement

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Arm 2Active Control1 Intervention

Active Comparator: Donor Stool Transplant Arm 2 will get FMT (Fecal Microbial Transplant) with Healthy Donor Stool into the jejunum through upper endoscopy.

Group II: Arm 1Placebo Group1 Intervention

Placebo Comparator placebo into the jejunum through upper endoscopy.

0 / 6Eligibility criteria met